On 12 May 2026, the Cyprus presidency of the European Council reached a provisional agreement with the European Parliament on the Critical Medicines Act, a new regulation designed to strengthen the resilience of the European pharmaceutical sector. The initiative is intended to address recurring shortages and improve the long-term availability and security of supply of both critical medicines and medicines considered strategically important for public health across the European Union.
The agreement comes at a time when European healthcare systems continue to face growing pressure linked to supply chain disruptions, geopolitical instability and increasing dependence on non-EU manufacturing for essential pharmaceutical ingredients.
Strengthening supply chains and EU manufacturing
Among the key measures included in the agreement is the diversification of pharmaceutical supply chains, aimed at reducing excessive reliance on a limited number of suppliers or geographic areas. The regulation also promotes joint and collaborative procurement mechanisms between member states, with the objective of improving coordination and ensuring faster access to essential medicines during periods of crisis or shortage.
Another central element of the proposed legislation is the strengthening of manufacturing capacity within the EU, particularly for critical medicines and their active pharmaceutical ingredients (APIs). The goal is to reinforce Europe’s strategic autonomy in the pharmaceutical sector and reduce vulnerabilities linked to external production hubs.
The provisional agreement also introduces new resilience-related requirements for public procurement procedures. Contracting authorities will be required to integrate criteria linked to supply security and continuity when purchasing medicines, encouraging more sustainable and reliable sourcing strategies.
New rules on procurement and contingency stocks
The text also lowers the threshold of member states required to request the European Commission to carry out procurement on their behalf, reducing the minimum number from nine countries to five. This change is expected to facilitate faster and more flexible joint purchasing initiatives among EU members.
In addition, the agreement specifies that contingency stock requirements must remain transparent and comply with the principles of solidarity and proportionality, in order to avoid imbalances between member states and prevent unnecessary pressure on supply systems.
The scope of the regulation has also been expanded to include orphan medicinal products in selected key therapeutic areas, reflecting increasing attention to the availability of treatments for rare diseases.
The provisional agreement will now need to be formally endorsed and adopted by both the Council and the European Parliament before the regulation can enter into force and move towards implementation.
